I know that other medical device companies are using Jira for their engineering efforts which means they also have to validate using their tools for the FDA documentation. I'm hoping there is an Intended User Validation report for Jira somewhere so we don't have to spend the time doing this task from scratch. I realize we'll have to add to it but it would be nice if there was something pre0existing for us to embellish it for our usage.
Hello @Jean Ann Harrison ,
As far as I know, there is no publicly available Validation documentation for Jira. We are working on providing a self-validation app for our tools (and thus validating some of the underlying Jira features), and we already have one for Confluence, but nothing for Jira itself at the moment.
We'll keep you in the loop if you are interested (I'm assuming you are on cloud).
If you prefer we can have a chat about it, see calendar below:
Regards
Matteo
Thank you for responding however, I am developing a validation protocol for our usage which will be sufficient for our regulating auditors. We need this validation complete within a few weeks and I just finished writing up our requirements which is also necessary too. I was only hoping there was something that already existed but since no one stated that they had one or used one, I'm developing one for our product. Appreciate your response though.
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Hello @Jean Ann Harrison ,
Welcome to Community !
Can you please share more about the intended User validation report?
Jira Cloud caters to so many reports, I am sharing the document to get an insights of them:
https://support.atlassian.com/jira-software-cloud/docs/generate-a-report/
I believe it's worth trying and reviewing them with the demo version.
Have a great day!
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Thank you for responding however my question wasn't about generating a report but instead if anyone has a validation report on using Jira for their engineering tasks/problems etc for developing their products. We are required to provide a report showing that all tool usage must show validated usage as evidence to the FDA. I'll be doing a customized version of an existing report but trying to repeat work if I can when it comes to generic validation.
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